Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
Compare with the code on your package — it is the most precise check available.
Drug: Misoprostol
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cytotec misoprostol NDC 00025-1461 |
200 ug/1 | Tablet Oral |
Pfizer Laboratories Div Pfizer Inc | Rx |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Lack of Assurance of Sterility
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Subpotent drug
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